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    • Ensures current Good Manufacturing Practices (cGMP) and Health Canada/Grifols Quality Systems are adhered to throughout the performance, documentation and…
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    • Working knowledge of Canadian regulations for medical devices, CTO (cells, tissues, and organs), drugs, natural health products, and cosmetics.
    • 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization.
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    • 7+ years’ experience in medical device or biologics regulatory affairs.
    • Assess device related complaints for medical device reporting requirements.
    • 3+ years’ experience in medical device or biologics regulatory affairs.
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Field Validation Specialist
Grifols
·
3.0
Toronto, ON M5G 2H6
Full-time
Apply on company site

Job details

Pay information not provided
Full-time
4 hour shift
Toronto, ON M5G 2H6

Full job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.


Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.



Field Validation Specialist

Ensures current Good Manufacturing Practices (cGMP) and Health Canada/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Grifols Canada Plasma Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing.


  • Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
  • Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry
  • Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.
  • Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.
  • Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
  • Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry:
    • Writes test cases to validate critical control points, user requirements, and functional designs.
    • Executes test cases as needed
    • Prepares validation reports for distribution
    • Ensures milestones and timelines are met on assigned projects
  • Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process:
    • Prepares validation equipment for use at the Donor Center and for evaluation upon return.
    • Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.
    • Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.
    • Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes
  • Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

EDUCATION
Bachelor's degree

EXPERIENCE
Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

KNOWLEDGE | SKILLS | ABILITIES
Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.

Occupational Demands Form: Work is performed in an office and in a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment is required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Perform tasks by following a set of written or oral instructions/procedures.

Travels on-site to plasma donation centers up to 50% - 75% as needed to ensure timely validation completion within the Geo.

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